NDC 64616-050-01 - Pediatric Earache Remedy

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 64616-050
Requested NDC: 64616-050-01
Package NDCs from labels: 64616-050-01, 64616-050-02
Manufacturer: Vitality Works, Inc | Vitality Works, Inc.
Effective date: 2025-12-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Ear Drops - Vitality Works, Inc \| Vitality Works, Inc.	Vitality Works, Inc \| Vitality Works, Inc.	2025-12-17	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64616-050-01	Pediatric Earache Remedy	15 mL in 1 BOTTLE, DROPPER	LIQUID	15		9
64616-050-02	Pediatric Earache Remedy	1 in 1 CARTON	LIQUID	1		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64616-050	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	8	Current NDC, Legacy NDC, 2 package rows	20241212_5769ce2c-d2e1-4069-92cc-e38bee668daf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACONITUM NAPELLUS	ACTIVE INGREDIENT	U0NQ8555JD	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
PLANTAGO MAJOR	ACTIVE INGREDIENT	W2469WNO6U	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
VERBASCUM THAPSUS	ACTIVE INGREDIENT	C9TD27U172	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
ACONITUM NAPELLUS	ACTIVE MOIETY	U0NQ8555JD	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
PLANTAGO MAJOR	ACTIVE MOIETY	W2469WNO6U	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
VERBASCUM THAPSUS	ACTIVE MOIETY	C9TD27U172	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
CITRUS PARADISI SEED	INACTIVE INGREDIENT	12F08874Y7	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
OLEA EUROPAEA LEAF	INACTIVE INGREDIENT	MJ95C3OH47	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PEDIATRIC EARACHE REMEDY (EAR DROPS) LIQUID [VITALITY WORKS, INC]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 31 of 82 · 1,626 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Henry Schein, Inc.	88403fcf-a276-42c0-88b6-bd84a720b564	2025-05-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Bestmade Natural Products Aconitum Napellus	ACONITUM NAPELLUS	Bestmade Natural Products	2993aeb3-a327-1b94-e063-6394a90a6596	2025-05-27	Warnings	Exact identifier unii: U0NQ8555JD
Bestmade Natural Products - Mullein Ear Drops	BELLADONNA, CALENDULA, ECHINACEA, HYDRASTIS, MULLEIN OIL, VIOLA ODORATA	Bestmade Natural Products	299331bd-9318-6d80-e063-6294a90ab889	2025-05-27	Warnings	Exact identifier unii: C9TD27U172 unii: WQZ3G9PF0H
Camilia	MATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOT	Laboratoires Boiron	24246729-2d45-4d83-bc25-39db03e266d4	2025-05-27	Warnings	Exact identifier unii: G0R4UBI2ZZ
Virimmune	ACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, HAMAMELIS VIRGINIANA, INFLUENZINUM (2023-2024), MERCURIUS VIVUS, MORBILLINUM, NATRUM MURIATICUM, NUX VOMICA, SELENIUM METALLICUM, VISCUM ALBUM	Deseret Biologicals, Inc.	1d35a8ab-c06b-478d-8f7b-dbe9c7dbb3d4	2025-05-27	Warnings	Exact identifier unii: U0NQ8555JD
Heart Small Intestine Meridian Opener	ARSENICUM ALBUM, AURUM METALLICUM, BELLADONNA, CACTUS GRANDIFLORUS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, KALI CARBONICUM, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), PYROGENIUM, SPIGELIA ANTHELMIA	Deseret Biologicals, Inc.	5b693acf-acfd-42d9-b7ac-7c7b5923ed61	2025-05-27	Warnings	Exact identifier unii: WQZ3G9PF0H
Immune Support	ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, ASTRAGALUS MEMBRANACEUS, BAPTISIA TINCTORIA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CORTISONE ACETICUM, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINARUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM (2023-2024), LACHESIS MUTUS, MERCURIUS CORROSIVUS, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SANGUINARIA CANADENSIS, SPLEEN (SUIS), SULPHUR, THUJA OCCIDENTALIS,	Deseret Biologicals, Inc.	8906ed6e-3a64-47c2-bc41-ae5101aff69d	2025-05-27	Warnings	Exact identifier unii: U0NQ8555JD
Immu-n Waker	APIS MEL, ECHINACEA, HYDRASTIS, THUJA OCC, ACONITUM NAP, AGARICUS MUSC, ALLIUM SAT, ALOE, ARNICA, ARSENICUM ALB, BAPTISIA, BELLADONNA, BRYONIA, CALC CARB, CALENDULA, CAPSICUM, CARDUUS MAR, HEPAR SULPH CALC, IODIUM, LACHESIS, LYCOPODIUM, MERCURIUS VIV, NUX VOM, PHOS, PULSATILLA, RHUS TOX, SALVIA, SELENIUM, TARAXACUM, TARENTULA HISP, ZINC MET, ZINGIBER, ANTHRACINUM, AZADIRACHTA, INFLUENZINUM	Newton Laboratories, Inc.	35a8381a-7fed-ab93-e063-6394a90ae3d7	2025-05-21	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Immu-n Waker	APIS MEL, ECHINACEA, HYDRASTIS, THUJA OCC, ACONITUM NAP, AGARICUS MUSC, ALLIUM SAT, ALOE, ARNICA, ARSENICUM ALB, BAPTISIA, BELLADONNA, BRYONIA, CALC CARB, CALENDULA, CAPSICUM, CARDUUS MAR, HEPAR SULPH CALC, IODIUM, LACHESIS, LYCOPODIUM, MERCURIUS VIV, NUX VOM, PHOS, PULSATILLA, RHUS TOX, SALVIA, SELENIUM, TARAXACUM, TARENTULA HISP, ZINC MET, ZINGIBER, ANTHRACINUM, AZADIRACHTA, INFLUENZINUM	Newton Laboratories, Inc.	35a9e9f4-0cfa-a444-e063-6294a90ae6a5	2025-05-21	Warnings	Exact identifier unii: WQZ3G9PF0H unii: U0NQ8555JD
Aconitum Napellus 30X	ACONITUM NAPELLUS	Laboratoire Schmidt-Nagel Inc.	32fd6811-9ec9-7787-e063-6294a90aed2d	2025-05-20	Warnings	Exact identifier unii: U0NQ8555JD
Belladonna 30X	BELLADONNA	Laboratoire Schmidt-Nagel Inc.	33628150-4483-e973-e063-6294a90a05d8	2025-05-20	Warnings	Exact identifier unii: WQZ3G9PF0H
Chamomilla 30X	CHAMOMILLA	Laboratoire Schmidt-Nagel Inc.	3362a2d9-9bbd-0490-e063-6294a90a3079	2025-05-20	Warnings	Exact identifier unii: G0R4UBI2ZZ
Inflammation I	ECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEA	BioActive Nutritional, Inc.	ddfad5cd-c928-42c0-9562-9feebb73a2cb	2025-05-19	Warnings	Exact identifier unii: WQZ3G9PF0H
Throat Formula	BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM	BioActive Nutritional, Inc.	6218a61a-4b5a-4ed2-bb8b-301dd898739e	2025-05-19	Warnings	Exact identifier unii: WQZ3G9PF0H
Lymph I	ECHINACEA (ANGUSTIFOLIA), KALI IODATUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, HYPOPHYSIS SUIS, APIS MELLIFICA, ARANEA DIADEMA, BELLADONNA, CALCAREA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, GALIUM APARINE, GRAPHITES, LACHESIS MUTUS, MERCURIUS PRAECIPITATUS RUBER, MYRISTICA SEBIFERA, PHOSPHORUS, RHUS TOX, SCROPHULARIA NODOSA, SULPHUR, THYROIDINUM (SUIS), VESPA CRABRO	BioActive Nutritional, Inc.	d3499253-ef69-4c95-ab96-2399b7a13de5	2025-05-16	Warnings	Exact identifier unii: WQZ3G9PF0H
ThroatSpray	ECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM	Energique, Inc.	3c4c3e7f-0ef9-4de0-b0bf-97fe7f6a527c	2025-05-16	Warnings	Exact identifier unii: WQZ3G9PF0H
BELLADONNA 30C - 3-Pack	BELLADONNA	SEVENE USA	31e1ac26-e613-5631-e063-6394a90a579c	2025-05-15	Warnings	Exact identifier unii: WQZ3G9PF0H
CHAMOMILLA 30C - 3-Pack	CHAMOMILLA	SEVENE USA	31e1cdc7-b32f-d36c-e063-6294a90a27c0	2025-05-15	Warnings	Exact identifier unii: G0R4UBI2ZZ
Eyesaline Emergency Eyewash	STERILE EYESALINE EYEWASH	Honeywell Safety Products USA, Inc.	2d567518-4c54-7448-e063-6294a90a3e64	2025-05-14	Warnings	Exact identifier unii: 059QF0KO0R
Airway Ease	INFLUENZINUM, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., KALI CARB., KALI IOD., MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, RUMEX CRISP., SAMBUCUS NIG., SPONGIA, TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA.	Newton Laboratories, Inc.	969d473d-4d59-6345-e053-2995a90a6c49	2025-05-07	Warnings	Exact identifier unii: C9TD27U172

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.